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FDA gives priority review status to BMS/ AZ’s metreleptin

Former obesity prospect has potential in the rare disease lipodystrophy

- PMLiVE

EMA backs Pomalidomide Celgene in multiple myeloma

Further positive CHMP opinions for new medicines form Aegerion, Teva and more

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FDA clears two GSK melanoma drugs

Tafinlar and Mekinist approved in the US along with companion diagnostic

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FDA gives Alexion’s metabolic drug breakthrough status

Reduces requirements for registration, potentially speeding up approval

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US FDA approves Roche’s assay as first blood test to diagnose diabetes

Will help catch diabetes early in country where seven million people are undiagnosed

- PMLiVE

Merck & Co inches closer to US green light for insomnia drug

FDA panel backs suvorexant, although some concerns about high dosages

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France ignores EMA and suspends Bayer’s Diane 35

National Agency for the Safety of Drugs and Health Products contradicts PRAC verdict

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EMA says Bayer’s Diane 35 should remain on European market

Agency investigation concludes acne treatment's benefits outweigh its risks

- PMLiVE

J&J’s Simponi wins FDA approval in ulcerative colitis

Adds to rheumatoid arthritis, psoriatic arthritis and active ankylosing spondylitis indications in the US

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FDA clears Bayer/ Algeta’s prostate cancer radiotherapy

Approval for Xofigo comes three months ahead of schedule

- PMLiVE

Novo Nordisk: Strict US regulation threatens innovation

Warning from CEO Sorensen comes after Tresiba and Ryzodeg fail to win FDA approval

- PMLiVE

FDA expands use of Roche/ Astellas’ Tarceva in lung cancer patients

New indication approved alongside companion diagnostic to detect gene mutation

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